Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)

Coronary Artery Disease Clinical Trial

— LONG-DES-IV  

Official title:

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186094
• Other study ID #: 2008-0086
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: August 6, 2012
• Start date: May 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long coronary lesions.

Description:

Following angiography, patients with significant diameter stenosis >50% and lesion length (> 25mm) requiring single or multiple long-stent placement (total stent length>28mm) by visual estimation and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be at least 18 years of age.

• Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)

• Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction

• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.

• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.

• Acute ST-segment-elevation MI or cardiogenic shock

• Terminal illness with life expectancy <1 year

• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

• In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)

• Patients with EF<30%.

• Serum creatinine level >=3.0mg/dL or dependence on dialysis.

• Patients with left main stem stenosis (>50% by visual estimate).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cypher
Sirolimus-eluting stent
• Endeavor Resolute
Zotarolimus-eluting Stent

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeong-gi
Korea, Republic of	Busan Paik Hospital	Busan
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Gangwon National University Hospital	Chuncheon
Korea, Republic of	Yeungnam University Medical Center	Daegu	Kyung-book
Korea, Republic of	Konyang University Hospital	Daejeon	Chungnam
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan	Gyeong-gi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kyung Hee University Medical Hospital	Seoul
Korea, Republic of	Stcarollo Hospital	Suncheon	Cheon-nam
Korea, Republic of	Wonju Christian Hospital	Wonju	Kangwon

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea, Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late luminal loss		9 month follow-up	No
Secondary	All Death		1 year	Yes
Secondary	Cardiac death		1 year	Yes
Secondary	Myocardial infarction (MI)		1 year	Yes
Secondary	Composite of death or MI		1 year	Yes
Secondary	Composite of cardiac death or MI		1 year	Yes
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		1 year	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		1 year	No
Secondary	Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)		12 months	Yes
Secondary	Stent thrombosis (ARC criteria)		1 year	Yes
Secondary	In-stent late loss at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	In-stent and in-segment restenosis at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	Angiographic pattern of restenosis at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)		at 9 month angiographic follow-up	No
Secondary	Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)		at 9 month angiographic follow-up	No
Secondary	Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.	At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)	at 3 days in average	No
Secondary	All death		one month	Yes
Secondary	All death		9 months	Yes
Secondary	Cardiac death		one month	Yes
Secondary	Cardiac death		9 months	Yes
Secondary	Myocardial infarction (MI)		one month	Yes
Secondary	Myocardial infarction (MI)		9 months	Yes
Secondary	Composite of death or MI		one month	Yes
Secondary	Composite of death or MI		9 months	Yes
Secondary	Composite of cardiac death or MI		one month	Yes
Secondary	Composite of cardiac death or MI		9 months	Yes
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		one month	No
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		9 months	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		one month	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		9 months	No
Secondary	Stent thrombosis (ARC criteria)		one month	Yes
Secondary	Stent thrombosis (ARC criteria)		9 months	Yes